FDA 483 - Neogen Culture Media - April 07, 2025

An FDA inspection of Neogen Corporation in Lansing, MI, revealed significant deficiencies in their medical device quality system. The firm failed to adequately establish procedures for corrective and preventive actions, process validation, complaint handling, design changes, product identification, supplier control, device history records, and device master records. Several critical observations, including those related to CAPA and process validation, were repeat findings from previous inspections.